Documentation structure - Do I need Work Instructions?

John Broomfield

Staff member
Super Moderator
#21
Indeed, and yet we still see many documented procedures without process objectives and documented instructions without task objectives.

Instead we often see the purpose of the document stated without any reason for doing the work.
 
Elsmar Forum Sponsor

Jim Wynne

Staff member
Admin
#22
I offer this contrast as an analogy in discussion of detailed work instructions versus relying on the judgement and competence of workers to get the job done efficiently and expeditiously.
Indeed, and yet we still see many documented procedures without process objectives and documented instructions without task objectives.

Instead we often see the purpose of the document stated without any reason for doing the work.
There is a long-persisting fallacy--a straw man of sorts-- about work instructions that's reflected here. One of the hallmarks of competence is the ability to operate a process without having to refer to documented instructions. Instructions don't impede competent people. They're handy for neophytes, of course, which is a good enough reason for them to exist, but there's another important purpose for them--they serve as a record of process design.

I also think we know what the purpose of a document is, and the objective of the process, without it being spelled out--we all know the "...reason for doing the work."
 

James

Involved In Discussions
#23
I offer this contrast as an analogy in discussion of detailed work instructions versus relying on the judgement and competence of workers to get the job done efficiently and expeditiously. Both football and futbol players are "trained" skilled athletes, both know what Success looks like, but the futbol/soccer player is more consistent with the definition of Lean in the modern era.
I think that depends on the level of the judgement and competence of the staff involved; John Seddon has written extensively about this. In my experience of applying 9001 to the service sector, relying on the judgement of workers can be a bad idea; the "right thing to do" can look very different to different people; particularly those who might not arrive at your door with relevant qualifications. Even when they have a relevant qualifications, all qualification assessments and awarding bodies are not equal. That said, there's a balance to strike and i agree that written detail for the sake of it is a bad idea too.
 

mmasiddiqui

Involved In Discussions
#24
Hi all

Just wondered if anyone thinks this approach will be an issue? The system sits in a wider corporate and divisional structure.

I'm also thinking that instead of work instructions, I'll specify Device quality indicators instead? - appropriate?

View attachment 26624
I would hesitate to call it otherwise, unless its your company's buzz word you like to use. Keeping or maintaining the Industry keywords help new people understand what you are talking about. Again, as long as the information from the documents flow smoothly, it will not be a problem.
 
Thread starter Similar threads Forum Replies Date
T Information and Structure for Technical Documentation for Firmware ISO 13485:2016 - Medical Device Quality Management Systems 1
A Documentation Confusion - Agile BOM Structure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T Quality Manual shall Outline Structure of Documentation - Clause 4.2.2 ISO 13485:2016 - Medical Device Quality Management Systems 10
Q ISO 13485 Clause 4.2.2 Documentation Structure - Quality Manual clarification ISO 13485:2016 - Medical Device Quality Management Systems 6
C Structure and Content of DMR / Technical Documentation (FDA vs. ISO 13485)? Document Control Systems, Procedures, Forms and Templates 6
GStough Outline of the Structure of Documentation in Quality Manual ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
U AS9100 Documentation structure and details - Seeking Advice Document Control Systems, Procedures, Forms and Templates 3
P ISO/TS 16949:2002 Documentation Structure IATF 16949 - Automotive Quality Systems Standard 6
G Structure in ISO 9001 documentation - Level 1, Level 2, Level 3, Level4, etc. Document Control Systems, Procedures, Forms and Templates 7
B Documentation Structure - What Do You Think? Document Control Systems, Procedures, Forms and Templates 17
S Need ISO 15189:2012 Documentation toolkit. Document Control Systems, Procedures, Forms and Templates 0
H MD Technical Documentation and SALES possibility EU Medical Device Regulations 0
A DMDIV-Variants : definition and technical documentation CE Marking (Conformité Européene) / CB Scheme 4
NDesouza COTS Items CoC for FAI Documentation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
P MDR/IVDR Annex III - Technical documentation on PMS EU Medical Device Regulations 1
I IATF Lab Scope Testing Qualification and Competency Documentation IATF 16949 - Automotive Quality Systems Standard 3
C Documentation hold during submissions? ISO 13485:2016 - Medical Device Quality Management Systems 0
K SOUP (Software of Unknown Provenance) Anomaly Documentation IEC 62304 - Medical Device Software Life Cycle Processes 2
C Gobys for operations documentation plan Oil and Gas Industry Standards and Regulations 4
C Refreshing an old and boring topic - Job descriptions and Roles vs Process Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
C Documentation for items used for Design Verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
J Where to Place Process Maps in our Documentation? Process Maps, Process Mapping and Turtle Diagrams 4
C Manufacturing overages & nonconforming material documentation ISO 13485:2016 - Medical Device Quality Management Systems 3
Robert Stanley Required Documentation Templates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
I Maintaining Technical Documentation under MDD and MDR EU Medical Device Regulations 1
M Basic UDI and technical documentation EU Medical Device Regulations 1
I Control of Documentation Distribution - Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M What is the average time needed for process documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
was named killer CLOUD BASED QUALITY DOCUMENTATION vs. SERVER BASED Document Control Systems, Procedures, Forms and Templates 5
S How to start with ISO process in project based team - Documentation Document Control Systems, Procedures, Forms and Templates 4
K ITAR Visitor Documentation of Citizenship AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
R Design Verification Documentation ISO 13485:2016 - Medical Device Quality Management Systems 19
A Process Documentation for ISO 9001:2015 Internal Auditing 2
F Process Review - What is the ISO requirement for reviewing SOPs and quality documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Good Documentation Practices Self Test? ISO 13485:2016 - Medical Device Quality Management Systems 6
F ISO 17025:2017 mandatory documentation requirements ISO 17025 related Discussions 1
D Virtual Documentation via Master Flow Chart? Process Maps, Process Mapping and Turtle Diagrams 4
S Defining a Quality System from scratch - Preferred system and documentation names Document Control Systems, Procedures, Forms and Templates 4
C Maintenance of Product Technical Documentation EU Medical Device Regulations 3
F PPAP Documentation Control APQP and PPAP 8
V Every good documentation practice observation is an data integrity issue US Food and Drug Administration (FDA) 7
CPhelan Labeling template on QMS - Kitting and labeling documentation Manufacturing and Related Processes 9
DuncanGibbons Documentation aerospace OEMs require with purchase of parts from manufacturers/suppliers Manufacturing and Related Processes 0
V What is the criteria to cite an good documentation practices observation as an data integrity related issue US Food and Drug Administration (FDA) 6
L AS9100 D- Handling Nonconformance Documentation for an organization that outsources most of the work. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
L ISO 9001:2015 standard documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
N Time source for paper-based documentation (research nurses) US Food and Drug Administration (FDA) 1
W Documentation - Use of Addendum vs Amendment Document Control Systems, Procedures, Forms and Templates 1
I What level of change in documentation requires re-training? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5

Similar threads

Top Bottom